AIDERA DIASEND SYSTEM
FDA 510(k) clearance K101806 · decided 2010-12-07
Clearance details
- K-number
- K101806
- Device name
- AIDERA DIASEND SYSTEM
- Applicant
- Aidera AB
- Decision
- Substantially Equivalent
- Date received
- 2010-06-28
- Decision date
- 2010-12-07
- Days to decision
- 162 days
- Clearance type
- Traditional
- Product code
- MRZ
- Device class
- 2
- Regulation number
- 880.5725
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Goteborg, SE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.